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Vapofil

by Southmedic, Inc. 2 variants

510(k) K945993

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK945993 Date22 Feb 1995ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1190-06 FDA Unclassified (pre-2012) initiated 21 Apr 2006
    • Terminated Z-1189-06 FDA Unclassified (pre-2012) initiated 21 Apr 2006

    Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia and surgery, and may damage certain plastic equipment. Leakage may also expose patients to low concentrations of volatile anesthetics.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CAD
Device Class
Class II
Regulation
21 CFR Part 868.5880
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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